The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block

The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block - a Prospective, Single-center, Randomized, Controlled Trial

In this single-center, randomized, parallel control clinical trial, patients will be randomly assigned to two groups. The treatment group receives ultrasound-guided erector spinae plane block with routine treatment of Acute Gastrointestinal Injury (AGI) for 7 days or until transferred to the general ward, while the control group only receives routine treatment of AGI. The primary outcome is the cure and remission rate of AGI.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Disease
• Intervention / Treatment: Drug: Ropivacaine injection

Detailed Description

Detailed Description:

Study title: The treatment of Acute Gastrointestinal Injury via ultrasound-guided erector spinae plane block - a prospective, single-center, randomized, controlled trial

Principal Investigator: Professor Wang Hua, Department of Critical Care Unit, Zhujiang Hospital of Southern Medical University

Study subjects: Patients age from 18 to 80 with AGI Ⅱ or greater

Study phase: Investigator Initiated Trial(IIT)

Primary objectives:

To evaluate whether ultrasound-guided erector spinae plane block can reduce the grade of AGI , and improve the cure and remission rate of AGI.

Experimental Group:

On the basis of routine clinical treatment, the ultrasound-guided erector spinae plane block intervention is given. On the first day enrolled, patients are performed with ultrasound-guided erector spinae plane block and cannula will be placed on T8 bilaterally. 0.375% ropivacaine of 20ml is injected separately to both sides with 2ml per hour. Injection is performed twice a day for 7 days or until transferred to the general ward.

Controlled Group:

The patients will receive the clinical routine treatment according of AGI recommended by the 2012 European Society of Critical Care Medicine guidelines, with a uniform nutritional strategy(gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy).

Course: 7 days Sample size: 100 Sites: 1

Primary endpoints:

1. the cure rate of AGI
2. the remission rate of AGI

Secondary endpoints:

1. critical ill scores
2. Gastrointestinal function indicators
3. The inflammatory indicators
4. the lactic acid(Lac)
5. cross-sectional area of pyloric antrum(AS) with ultrasound
6. width of the colons with abdominal X ray or CT
7. the 28-day mortality
8. gastrointestinal dysfunction and duration (GIF)

Additional endpoints:

1. The length of stay in ICU
2. The total days of hospitalization

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. AGI are diagnosed according to the diagnostic criteria proposed by European Society Intensive Care Medicine (ESICM) in 2012 and the AGI grade great than or equal to II.
2. Age 18-80 years.
3. Expected length of stay longer than 3 days.

Exclusion Criteria:

1. Mean arterial pressure is still less than 65 millimeter of Mercury (mmHg) treated with rehydration and vasoactive agents, or with the dosage of norepinephrine more than 0.5ug/kg/min.
2. Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker.
3. Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation.
4. Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history.
5. Neuromuscular disorders.
6. Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders.
7. Pregnancy.
8. Brain dead.
9. Malignant tumor, or end-stage cachexia.
10. With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization.
11. Allergy to local anesthetics.
12. Significant abnormalities in blood coagulation parameters.
13. Without written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; On the basis of the clinical routine treatment of AGI in severe patients, the Experimental Group will receives ultrasound-guided erector spinae plane block with routine treatment of AGI for 7 days or until transferring to the general ward.	Drug: Ropivacaine injection; On the first day of inclusion, performed T8 bilateral ultrasound-guided erector spinae plane block and indwelling tube will be left + 0.375% ropivacaine 20ml to both sides. Patients will be given injections every 12 h for 7 days.; Other Names: ropivacaine
No Intervention: Controlled Group; the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the cure rate of AGI	the cure rate of AGI on the day3	on the day3
the cure rate of AGI	the cure rate of AGI on the day7	on the day7
the remission rate of AGI	the remission rate of AGI on the day3	on the day3
the remission rate of AGI	the remission rate of AGI on the day7	on the day7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Physiology and Chronic Health Evaluation(APACHE II)	measuring endpoints include: body temperature mean arterial pressure (MAP) heart rate (HR) respiratory rate (RR) fraction of inspiration O2 (FIO2) potential of hydrogen (PH) Na+ K+ serum creatinine (SCr) hematocrit (Hct%) white blood cell (WBC) Age immunosuppression before/after surgery or serious organ dysfunction (Higher score means a worse outcome.)	on the day 0,1,3 and 7
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score	SOFA score evaluate status of the following organ systems separately: (Higher score means a worse outcome.); Respiration Partial Pressure of Oxygen/Fraction of Inspiration O2 (PaO2/FiO2); Coagulation Platelets; Liver Bilirubin; Circulatory Mean arterial pressure; Central Nervous System Glasgow coma score; Renal Creatinine (or urine output)	on the day 0,1,3 and 7
the intraperitoneal pressure(IAP)	Gastrointestinal function indicators	on the day 0,1,3 and 7
abdominal perfusion pressure(AAP)	Gastrointestinal function indicators	on the day 0,1,3 and 7
total gastric residual volume(GRVs)	Gastrointestinal function indicators	on the day 0,1,3 and 7
feeding dose	Gastrointestinal function indicators	on the day 0,1,3 and 7
Gastrointestinal dysfunction and duration(GIF)	fasting(score 1 point); reflux(score 2 points); gastrointestinal decompression(1 point); Gastric retention(2 points); abdominal distension(2 points); abdominal pain(2 points); diarrhea(2 points); hypoactive bowel sounds(1 point); bowel sounds disappear(2 points); constipation(2 points) The mentioned indicators will be combined to report GIF in score. Grade 0 (Normal) : 0 score Grade 1 (Mild) : 1~4 score Grade 2 (Medium) : 5~9 score Grade 3 (Serious) : >10 score	on the day 0,1,3 and 7
Width of the colons	width of the right colons with abdominal X ray or CT	on the day 0,1,3 and 7
White Blood Cell(WBC)	The inflammatory indicators	on the day 0,1,3 and 7
Interleukin-6(IL-6)	The inflammatory indicators	on the day 0,1,3 and 7
Cross-sectional area of pyloric antrum(AS)	cross-sectional area of pyloric antrum(AS) with ultrasound	on the day 0,1,3 and 7
Lymphocyte (LYM)	The inflammatory indicators	on the day 0,1,3 and 7
Neutral Granular Cell(NEUT)	The inflammatory indicators	on the day 0,1,3 and 7
Procalcitonin (PCT)	The inflammatory indicators	on the day 0,1,3 and 7
Hypersensitive C Reactive Protein(HSCRP)	The inflammatory indicators	on the day 0,1,3 and 7
The lactic acid(Lac)	the serum level of the lactic	on the day 0,1,3 and 7
The 28-day mortality	the 28-day mortality	From enrolled to 28 days or the termination date
The length of stay in ICU	From the date of ICU admission to transfered out.	on the day 28 or through study completion
The total days of hospitalization	from hospital admission to hospital discharge.	on the day 28 or through study completion

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Hua Wang, MD,PhD, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Ropivacaine; Acute gastrointestinal injury; Erector spinal muscle plane block
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2020-KY-032-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No